| Trial ID: | L2330 |
| Source ID: | NCT05318326
|
| Associated Drug: |
Placebo Group
|
| Title: |
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: placebo group|DRUG: Yogliptin 400mg group|DRUG: Yogliptin 200mg group
|
| Outcome Measures: |
Primary: HbA1c change from baseline at week 24, Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24, Baseline and week 24 | Secondary: FPG Change From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|2h-PPG Change From Baseline at Week 24 and Week 44 and Week 52, Baseline, week 24 and Week 44 and Week 52|Percentage of Patients With HbA1c <6.5%, Time Frame: Baseline, week 24 and week 52|Percentage of Patients With HbA1c <7.0%, Baseline, week 24 and week 52|blood pressure Change From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Weight Change From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Fasting lipids From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52
|
| Sponsor/Collaborators: |
Sponsor: Chengdu Easton Biopharmaceuticals Co,Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
450
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-01-01
|
| Completion Date: |
2024-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-20
|
| Locations: |
Beijing Hospital, Beijing, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05318326
|
